CStone Receives the US FDA IND Clearance to Initiate P-II Trial of CS2009 in Advanced Solid Tumors

Shots: The US FDA has granted IND Clearance to initiate P-II trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) in pts with advanced solid tumors CS2009 is being evaluated in a P-II trial (currently enrolling) across Australia & China, spanning 15 cohorts to evaluate monotx. & combination regimens in 9 solid tumors, incl. NSCLC, colorectal cancer, TNBC,…

ByRidhi RastogiFebruary 17, 2026

NEWS

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

Shots: The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced…

ByRidhi RastogiFebruary 16, 2026

NEWS

PRN Pharmacal Receives the Full US FDA Approval for KBroVet to Control Seizures in Dogs with Idiopathic Epilepsy

Shots: The US FDA has granted full approval to KBroVet (potassium bromide chewable tablets) under NADA for the control of seizures associated with idiopathic epilepsy in dogs KBroVet offers benefits for dogs, incl. renal excretion via glomerular filtration for those with liver issues, once-daily dosing, & flavored, chewable tablets formulated specifically for dogs KBroVet has a…

ByRidhi RastogiFebruary 13, 2026

NEWS

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Shots: The US FDA has granted 510(k) clearance to Encora X1 to help relieve hand tremors in the treated limb during stimulation in adults with essential tremor Clearance was backed by a sham-controlled trial & a 90-day home-use study, both demonstrating improvements in tremor severity & functional tasks, supporting the device’s ability to assist with…

ByRidhi RastogiFebruary 13, 2026

NEWS

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Shots: The US FDA has granted IND Clearance to initiate P-II PoC trial of AK3280 in the US for the treatment of idiopathic pulmonary fibrosis (IPF) The P-II PoC trial will evaluate AK3280 (PO) vs PBO & an active comparator in IPF pts, aiming to generate key clinical data to support future regulatory filings &…

ByRidhi RastogiFebruary 12, 2026

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Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Shots: Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…

ByRidhi RastogiFebruary 12, 2026

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Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Shots: Approval was based on the P-III (PANOVA-3) trial assessing Optune Pax, a TTFields device used concomitantly with gemcitabine & nab-paclitaxel (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In mPP (198 received Optune…

ByRidhi RastogiFebruary 12, 2026

NEWS

Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

Shots: The US FDA has granted RMAT Designation to KB707 for the treatment of advanced or metastatic NSCLC Designation was supported by the ongoing P-I/II (KYANITE-1) trial assessing KB707 (administered via nebulization) across 7 cohorts: Arms 1-4 as monotx., Arm 5 with Keytruda, Arm 6 with Keytruda & CT & Arm 7 with CT alone…

ByRidhi RastogiFebruary 10, 2026

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Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Shots: The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26 NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…

ByRidhi RastogiFebruary 10, 2026

NEWS

Median Technologies Receives the US FDA’s 510(k) Clearance for eyonis LCS for Lung Cancer Detection and Diagnosis

Shots: The US FDA has granted 510(k) clearance to eyonis Lung Cancer Screening (LCS), an AI/ML-powered CADe/CADx software, to detect & diagnose lung cancer eyonis LCS analyzes LDCT imaging to help radiologists detect & characterize pulmonary nodules, enabling earlier diagnosis; in testing it showed 93.3% sensitivity, 92.4% specificity & 99.9% NPV, minimizing false positives &…

ByRidhi RastogiFebruary 9, 2026

CStone Receives the US FDA IND Clearance to Initiate P-II Trial of CS2009 in Advanced Solid Tumors

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

PRN Pharmacal Receives the Full US FDA Approval for KBroVet to Control Seizures in Dogs with Idiopathic Epilepsy

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Median Technologies Receives the US FDA’s 510(k) Clearance for eyonis LCS for Lung Cancer Detection and Diagnosis

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